Evidence map›Paper›PMID 31664782›Full record

Trial reportClinical and translational science2020

Itraconazole Increases Ibrutinib Exposure 10-Fold and Reduces Interindividual Variation-A Potentially Beneficial Drug-Drug Interaction.

Tuija Tapaninen, Aleksi M Olkkola, Aleksi Tornio, Mikko Neuvonen, Erkki Elonen, Pertti J Neuvonen, Mikko Niemi, Janne T Backman

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05348096 (Efficacy and Safety of the Combination of Low-dose Ibrutinib and Itraconazole in Moderate to Severe Chronic Graft Versus Host Disease), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05348096 phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

Efficacy and Safety of the Combination of Low-dose Ibrutinib and Itraconazole in Moderate to Severe Chronic Graft Versus Host Disease: a Phase 2 Trial

TypeinterventionalSponsorHospital Universitario Dr. Jose E. GonzalezRan2022 to 2023Enrolled13ConditionsChronic Graft-versus-host-diseaseArmsLow-dose ibrutinib
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Bioinformatics Study of Flavonoids From GenusAdvances and applications in bioinformatics and chemistry : AABC · 2024
    Article
  10. Article
  11. Recommendations on the use of azole antifungals in hematology-oncology patients.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2023
    Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. Studies in mycology · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Tuija Tapaninen *Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.ORCID 0000-0003-4562-9606
Aleksi M Olkkola *Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Aleksi TornioDepartment of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.ORCID 0000-0001-5713-5692
Mikko NeuvonenDepartment of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Erkki ElonenDepartment of Hematology, Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki, Finland.
Pertti J NeuvonenDepartment of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.ORCID 0000-0003-3631-9411
Mikko NiemiDepartment of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.ORCID 0000-0003-4550-2189
Janne T BackmanDepartment of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.ORCID 0000-0002-9577-2788

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The oral bioavailability of ibrutinib is low and variable, mainly due to extensive first-pass metabolism by cytochrome P450 (CYP) 3A4. The unpredictable exposure can compromise its safe and effective dosing. We examined the impact of itraconazole on ibrutinib pharmacokinetics. In a randomized crossover study, 11 healthy subjects were administered itraconazole 200 mg or placebo twice on day 1, and once on days 2-4. On day 3, 1 hour after itraconazole (placebo) and breakfast, ibrutinib (140 mg during placebo; 15 mg during itraconazole) was administered. Itraconazole increased the dose-adjusted geometric mean area under the concentration-time curve from zero to infinity (AUC

Indexed as

AdenineAdministration, OralAdultAgammaglobulinaemia Tyrosine KinaseArea Under CurveBiological AvailabilityBiological Variation, PopulationCross-Over StudiesCytochrome P-450 CYP3ACytochrome P-450 CYP3A InhibitorsDrug InteractionsHealthy VolunteersHumansItraconazoleMalePiperidinesAdenineAgammaglobulinaemia Tyrosine KinaseBTK protein, humanCYP3A4 protein, humanCytochrome P-450 CYP3ACytochrome P-450 CYP3A InhibitorsibrutinibItraconazolePiperidines

Identifiers

PMID31664782
PMCPMC7070818

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.